510(k) K062004

MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT by Quantum Orthopedics, Inc. — Product Code MQP

K062004 is an FDA 510(k) premarket notification submitted by Quantum Orthopedics, Inc. for the device "MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT". The FDA issued a decision of Substantially Equivalent on August 15, 2006. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Quantum Orthopedics, Inc. has at least 5 other 510(k) clearances on record.